Document and Change Control Specialist

TalentBurst • Vista, CA

2d • Onsite

About The Position

The Document and Change System Specialist processes change requests and controlled documents in an electronic system. The role ensures changes that may affect the safety, purity, potency, or quality of manufactured products are reviewed, justified, documented, approved, and implemented in accordance with regulatory requirements and company policies and procedures.

The specialist manages change control documentation for cGMP manufacturing processes and SOPs across plasma centers and operations, coordinating reviews, approvals, implementation, training, customer communications, and records throughout each change’s lifecycle. The role also manages Quality System documentation from creation or revision through review, approval, distribution, effectivity, and obsolescence, including maintaining controlled electronic and archived records.

Work is performed in an office environment, with frequent driving to site locations and occasional travel within the United States. The position requires collaboration with corporate, field management, center-level customers, document stakeholders, and diverse groups to resolve issues and reach consensus.

Requirements

• Bachelor's degree in a scientific field.
• Strong knowledge of FDA regulatory requirements for good manufacturing practices.
• Demonstrated spreadsheet and database computer software skills.
• Excellent oral and written communication skills.
• Strong problem-solving skills and ability to follow assigned tasks through to completion.
• Attention to detail.
• Ability to prioritize and work independently with limited supervision.
• Ability to communicate information and ideas clearly and understand spoken and written information.
• Ability to interact with others and convey sensitive information to diverse groups.
• Ability to work with diverse groups to obtain consensus on issues.
• Ability to perform light to moderate lifting and carrying, with a maximum lift of 50 pounds.
• Ability to travel frequently by car to site locations and occasionally within the United States.

Responsibilities

• Ensure compliance with FDA regulations and policies, guidelines, and SOPs related to change and document control.
• Process change control requests for cGMP manufacturing processes and SOPs, including product or procedural, equipment, customer, supplier or contractor, and facility changes.
• Track and maintain change control documentation throughout its lifecycle and support timely completion of tasks.
• Coordinate change control activities and deliver change requests and information to customers, including plasma centers and plasma operations.
• Communicate with Corporate, Field management, and Center-level customers about change requests and shared or impacted processes.
• Review supporting documentation for content and formatting; work with requestors, owners, and reviewers to resolve concerns.
• Prepare changes for review and engage leadership and subject matter experts as needed.
• Conduct final reviews of change requests and documentation for completeness, including impact assessments and required action completion.
• Coordinate training on Change Control procedures.
• Respond to customer service requests and assist other departments as needed.
• Maintain master libraries or databases of change request documents, SOPs, forms, job aids, and training documents.
• Maintain secure filing and storage systems for archived hard-copy change requests and controlled documentation.
• Manage Quality System documents through processing, distribution, tracking, creation or revision, review, approval, effectivity, and obsolescence.
• Distribute customer specification documents to departments and point-of-use locations.
• Maintain the electronic document control system and control electronic document versions and archived files outside that system.
• Prepare and proof document content and formatting, coordinating with authors, owners, and reviewers to resolve concerns before issuance.
• Maintain document control calendars and databases and ensure document control procedures are updated according to established procedures and standards.
• Author Center Notifications as needed to communicate non-procedural updates to donor centers and leadership.

Benefits

• Medical benefits
• Dental benefits
• Vision benefits
• Retirement options

What This Job Offers

• Job Type: Full-time